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Trial record 4 of 45 for:    NOT MRI NOT Imaging NOT intensive NOT auditory NOT thermal NOT mirror NOT TENS NOT tactile NOT motion NOT Passy NOT music NOT flow NOT vibration NOT fluid NOT ASIS NOT traditional | Recruiting, Not yet recruiting, Available Studies | Stroke | Deep Brain Stimulation OR magnetic OR transcranial direct current

Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation Among Patients With Stroke

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ClinicalTrials.gov Identifier: NCT04055597
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea

Brief Summary:
Effects of upper extremity rehabilitation robot and transcranial direct current stimulation on upper extremity function among subjects with tremor after stroke

Condition or disease Intervention/treatment Phase
Stroke Other: Robot and tDCS on-line Other: Robot and sham tDCS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation on Upper Extremity Function Among Subjects With Tremor After Cerebellar and Brainstem Stroke
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Robot and tDCS on-line
Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot
Other: Robot and tDCS on-line
Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot for 5 times a week for 4 weeks

Sham Comparator: Robot and sham tDCS
Combined sham tDCS and upper extremity rehabilitation robot
Other: Robot and sham tDCS
Combined sham tDCS and upper extremity rehabilitation robot for 5 times a week for 4 weeks




Primary Outcome Measures :
  1. Change of Scale for the assessment and rating of ataxia [ Time Frame: Change of Scale for the assessment and rating of ataxia at 4 weeks after baseline compared to baseline ]
    Change of Scale for the assessment and rating of ataxia

  2. Change of Functional ataxia rating scale - upper limb [ Time Frame: Change of the Functional ataxia rating scale - upper limb, at 4 weeks after baseline compared to baseline ]
    Change of Functional ataxia rating scale - upper limb


Secondary Outcome Measures :
  1. Fugl-Meyer Assessment - upper extremity [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Fugl-Meyer Assessment - upper extremity

  2. Composite cerebellar functional severity score [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Composite cerebellar functional severity score (Nine hole peg test + click test)

  3. Jerk during reaching and finger pointing [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Kinematic data during reaching and finger pointing using Trakstar

  4. Smoothness during reaching and finger pointing [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Kinematic data during reaching and finger pointing using Trakstar

  5. Behavioral activation system/behavioral inhibition system scale [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
    In terms of motivation

  6. Beck's depression index [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Beck's depression index

  7. Stroke rehabilitation motivation scale [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Stroke rehabilitation motivation scale

  8. Intrinsic motivation inventory [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Intrinsic motivation inventory

  9. Numeric rating scale for upper extremity pain [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Question about the upper extremity pain (0-10; higher is better)

  10. Functional reaching test [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Functional reaching test

  11. modified Barthel index [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
    modified Barthel index

  12. % maximal voluntary contraction from upper extremity muscles during reaching task [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
    data from surface electromyography from upper extremity muscles during reaching task

  13. Kinematic data during scale for the assessment and rating of ataxia [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Kinematic data during scale for the assessment and rating of ataxia

  14. Scale for the assessment and rating of ataxia [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Scale for the assessment and rating of ataxia

  15. Functional ataxia rating scale - upper limb [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Functional ataxia rating scale - upper limb, kinematic data during scale for the assessment

  16. Kinematic data during scale during the Functional ataxia rating scale - upper limb [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Kinematic data during scale during the Functional ataxia rating scale - upper limb



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stroke with cerebellar hemorrhage or infarction
  • ataxia or tremor on upper extremities secondary to stroke
  • Cognitively intact enough to understand and follow the instructions from the investigator

Exclusion Criteria:

  • History of surgery of affected upper limb
  • Fracture of affected upper limb

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04055597


Contacts
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Contact: Joon-Ho Shin, MS 82-2-901-1884 asfreelyas@gmail.com

Locations
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Korea, Republic of
National Rehabilitation Center Recruiting
Seoul, Korea, Republic of, 142884
Contact: Joon-Ho Shin, MS         
Principal Investigator: Joon-Ho Shin, MS         
Sponsors and Collaborators
National Rehabilitation Center, Seoul, Korea
Investigators
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Principal Investigator: Joon-Ho Shin, MS National Rehabilitation Center

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Responsible Party: Joon-Ho Shin, Team manager, National Rehabilitation Center, Seoul, Korea
ClinicalTrials.gov Identifier: NCT04055597     History of Changes
Other Study ID Numbers: NRC-2017-01-004
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea:
cerebellar stroke
upper extremity rehabilitation robot
transcranial direct current stimulation
stroke rehabilitation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases